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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K837422
Device Name LASER PHOTOCOAGULATOR
Applicant
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Date Received04/22/1983
Decision Date 06/10/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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